Privatization of Knowledge and the Creation of Biomedical Conflicts of InterestLeemon B. McHenry Department of Philosophy, California State University, NorthridgeJon N. Jureidini Discipline of Psychiatry, University of Adelaide, South Australia
rather than to what is meaningful, so that fi ndings that are
Abstract
likely to be clinical and meaningful are rejected because they fail to reach statistical signifi cance whereas others that appear
Scientifi c and ethical misconduct have increased at an
clinically trivial are accepted (Ziliak and McCloskey, 2007). Th
alarming rate as a result of the privatization of knowledge.
disenchantment with the psychoanalytic paradigm of psychiatry
What began as an eff ort to stimulate entrepreneurship
led to a massive investment in psychopharmacology and other
and increase discovery in biomedical research by
physical interventions. A concession now to the limited benefi t
strengthening the ties between industry and academics
that psychopharmacology off ers would come at great cost to the
has led to an erosion of confi dence in the reporting of
profession. A vested interest in protecting the new paradigm of
research results. Inherent tensions between profi t-directed
neurological models of psychiatric disorders reaches beyond the
inquiry and knowledge-directed inquiry are instantiated
quest for a secure scientifi c foundation.
in psychopharmacology, especially in the co-option of academic activity to corporate objectives. The eff ects of
To the vulnerability created by personal bias and questionable
these tensions are visible in research agendas, publication
methodology we must add the dangers of pervasive fi nancial
practices, postgraduate education, academic-industry
confl icts of interest, of which we investigate the root cause in this
paper. With the privatization of knowledge comes a heavy burden of untangling the motives of profi t from the motives of scientifi c objectivity. Confl ict of interest has created an epistemological
Key Words: confl icts of interest, ethics, intellectual property
morass and a serious problem of credibility for the profession
law, key opinion leaders, knowledge-directed inquiry,
e bias created from researchers’ interests and
pharmaceutrical industry, privatization, profi t-directed inquiry
ambitions pales in comparison to bias due to the now pervasive infl uence of industry.
I n t r o d u c t i o nP r o f i t - D i r e c t e d I n q u i r y vs . K n o w l e d g e - D i r e c t e d I n q u i r y
here are many pressures that potentially undermine the disinterested status of an academic scientist. None are free of bias. We carry pre-conceptions and expectations
It is in industry’s interests to be competitive, protect discoveries and
into research yet rely on research methodology to counter these
strategies as trade secrets, demand product loyalty, and suppress
eff ects. Most at risk are those who fail to acknowledge bias. In
criticism, all to the end of gaining market share and maximizing
disciplines where research involves measurement, we rely on
profi t. As such, inquiry is profi t directed. By contrast, academe
developing objective measures so that outcomes are less susceptible
is a cooperative enterprise, characterized by free, open critical
to researchers’ judgments. Medical scientists are doubly vulnerable
inquiry and disinterest in the results of research in the pursuit of
and may need a greater level of protection from bias than many
truth and discovery of error. Richard Horton citing the American
ey are also likely to be infl uenced by their
historian Steven Shapin, contends that the two cultures of the
idiosyncratic experience with their own patients.
scientifi c and trading classes, or what we identity as the knowledge vs. profi t inquiry, were kept separate, to protect the integrity and
Psychiatry may be the branch of medicine that is most vulnerable
virtues of the former from the vices of the latter. Scientists were,
and are still meant to be, trusted to produce a reliable body of
Given the ascendancy of what Ziliak and McCloskey call the “cult
knowledge, while no such requirement is supposed from those
of statistical signifi cance,” researchers turn to what is measurable
who seek private advantage (Horton, 2004, 7).
JEMH · April 2009 · 4(Sept. Suppl.) | 1
2009 Journal of Ethics in Mental Health (ISSN: 1916-2405)
A marriage of these two very diff erent cultures or motives has
opinions of someone who is not sympathetic to its product. Few
produced a situation in which the profi t motive threatens the
physicians and psychiatrists can resist the lure of fame and fortune
ideal of intellectual inquiry. Addressing the most important needs
off ered by industry, but the primary motive of ethical duties to
of humanity becomes subservient to the pursuit of signifi cant
patients is compromised by profi table drug and medical device
revenue. But more importantly for our present concern, profi t
promotion; marketing directives threaten the accuracy of research
inquiry instantiated in the corporate model of the academy
results and university professors become what David Healy calls
has resulted in an alarming increase in scientifi c and ethical
“ornamental additions to business” (Healy, 2004, xv).
misconduct, especially in biomedical research. Th
that the industry-academe dichotomy has been sharply drawn
e rise of the KOL and academic entrepreneur coincides with
and immune from contamination until recently, but in our
what is arguably one of the most infl uential pieces of legislation to
view what might have been well-intentioned legislation to spur
impact the fi eld of intellectual property law—the Bayh-Dole Act of
entrepreneurship in the commercial development of research has
1980. Such legislation was explicitly designed for the privatization
accelerated the confl icts of interest and the resulting misconduct
of knowledge during Reagan Revolution in the United States, and
with virtually no regulatory oversight. In fact, the political motives
resulted from a shift in the philosophy of government from creating
that created the acceleration of confl icts of interest are the very
public wealth and safety nets for the less fortunate to maximizing
same ones that have considerably weakened regulation—all as a
private, for-profi t sections (Krimsky, 2004, 108).
by apologists, will correct product defects and expose corruption.
e Bayh-Dole Act created a uniform patent policy that allowed
Yet the harm to public health that has resulted from distortion in
universities to retain ownership to inventions made under
clinical research and the use of that research in drug promotion
federally-funded research. Previously the federal government
has made it clear that the marketplace is too slow or inept when
assumed ownership of the research it funded but it did not have
the resources to expedite transfer of technology for commercial development. Moreover, when the government granted non-exclusive licenses to businesses, competitors could acquire the
Th e P r i v a t i z a t i o n o f K n o w l e d g e a n d
same licenses and thus there was little incentive to enter into such
Co n f l i c t o f I n t e r e s t
e motivation behind Bayh-Dole was to speed
up the commercialization process of federally-funded research, create new industries and open new markets from the university-
Confl ict of interest is defi ned as a problem of competing motives.
patented inventions. Robert Kelch reports that: “since 1980, at
A confl ict of interest exists when one in a position of trust has
least 2900 companies have been formed that were built around
competing professional or personal interests which make it diffi
an innovation licensed by researchers at an academic institution”
to fulfi ll his or her duties impartially. We take as a case study the
United States pharmaceutical industry (by far the world’s biggest), and its relationship with Key Opinion Leaders (KOLs), particularly
e growth of university patents and the commercialization of
psychiatrists who are amongst those most generously supported by
research that followed Bayh-Dole at fi rst seemed to have nothing
pharma (Sorrell, 2008). In medicine, the phenomenon of the KOL
but positive eff ects, such as the innovations in the development
is a result of the industry-academic partnership that has become
of biotechnology and rapid development of pharmaceuticals, but
virtually synonymous with fi nancial confl ict of interest. KOL’s are
it soon became clear that the legislation had opened a Pandora’s
individuals who act as consultants, researchers and teachers for
Box. Universities that were losing government funding found the
e relationship is mutually benefi cial to the
new source of revenue in the technology transfer to industry, but
KOLs and the companies but not necessarily to patients. For the
at the price of a proliferation of confl icts of interest. It increased
company, it provides an apparently independent expert to publish
consulting arrangements with greater emphasis on intellectual
and speak on behalf of its products. For the academic, it off ers
property (Krimsky, 2006, 22) and created a culture of secrecy that
kudos, research income, publications (including invitations to
“may actually have slowed the sharing of scientifi c information
co-author infl uential papers that are largely ghost-written) and a
and the exploration of new scientifi c leads” (Angell, 2004, 203).
profi le at major congresses. It also off ers great fi nancial benefi t.
e most disturbing aspect of these arrangements, however, is the
As the inquiries of US Senator Charles Grassley have revealed,
manipulation of research results in favor of the sponsor company’s
senior KOLs have failed to disclose the extent of their fi nancial
entanglements with industry (Grassley, 2008). We can only guess at the degree of infl uence this undeclared income has had on their
e secrecy involved in privatization created another obstacle
practice, but even absent any fi nancial irregularities, KOLs are
to scientifi c progress since a signifi cant portion of industry
subject to infl uence through the benefi t to their academic careers.
misconduct in clinical research is protected under the intellectual property law called “the Uniform Trade Secrets Act.” Th
Pharmaceutical companies take considerable eff ort in recruiting
legislation prevents release of important information on the basis
KOLs they identify as malleable to their purpose by carefully
of the alleged necessity of protecting commercial interests that
monitoring a potential KOLs’ prescribing and research. A young
academic might be supported in research or asked to teach. If the company likes what it hears, its investment in the KOL will
Pharmaceutical companies under challenge by legal proceedings to
e KOLs need never feel that they are being infl uenced
release information to the public routinely claim protection under
the aegis of trade secrets. While some documents are unsealed
existing conducive attitudes rather than attempt to change the
and released to the public because they are already in the hands of
JEMH · April 2009 · 4(Sept. Suppl.) | 2
2009 Journal of Ethics in Mental Health (ISSN: 1916-2405)
a third party such as a peer-reviewed journal or a Public Relations
from negative trials (Ross et al, 2008, Steinman et al, 2006). Others
agency, the majority of critical documents remain unknown to the
such as drotrecogin alfa (Xigris) and aprotinin (Trasylol) reveal
further instances of manipulation of data and marketing hype
that reveal exploitation of academics or physicians for marketing
(Singh and Singh, 2007a, 2007b). Indeed as Krimsky reports,
and promotion purposes, budgets that include payments to KOLs
this is just the proverbial tip of the iceberg since the majority of
and medical communication companies that have produced
cases remain undisclosed (Krimsky, 2004, 9). Industry-sponsored
ghostwritten publications, advisory board and speakers’ symposia
trials conducted by academic investigators are prime examples of
members, marketing agendas that describe manipulation of the
the harm done to the reputation of clinical research in the wake
peer-reviewed medical journals, programs designed to increase
e paper that reported study 329, for example,
patient compliance, secret liaisons with patient support groups,
claimed that: “paroxetine is generally well tolerated and eff ective
disease mongering, and the results of negative clinical trials. Only
for major depression in adolescents” (Keller et al, 2001). Yet
occasionally does anything of this sort see the light of day and
documents obtained during litigation reveal that study 329 was
only because of attorneys’ errors in submitting documents to the
cacy on all eight protocol specifi ed outcomes and
court or because an industry insider has smuggled documents
by removing four of the eight negative outcome measures specifi ed
uses of the Trade Secrets Act such as protecting discoveries of new
in the protocol and replacing them in the published paper with
molecular entities from industrial espionage, but the abuse of the
positive ones (two of which were introduced aft er breaking the
Act in order to protect companies from discovery of misconduct
blind), and by confl ating measures to give the false impression that
and fraud only adds to the general problem that privatization has
one of the primary outcomes was positive (Jureidini et al, 2008).
created for the attempt at reliable science.
Harms were either not reported or glossed over.
When the Keller et al paper was published, paroxetine was
Th e Co n s e q u e n ce s o f P r i v a t i z a t i o n i n
vigorously promoted to SKB/GSK sales representatives as
M e d i c a l R e s e a r c h
treatment of adolescent depression” (Hawkins, 2001), and the same message was delivered to the psychiatric community by
Sheldon Krimsky has documented well the misconduct that
KOLs, who frequently did not disclose the results for the primary
has resulted from the academic-industry alliance that makes
outcomes and serious adverse events (see, for example, Keller 1998,
knowledge the property of for-profi t companies (Krimsky, 2003).
Berard et al, 1998, Wagner et al, 1998, Gagiono, 1999, Wagner,
We wish to expand Krimsky’s thesis with further evidence of
2003). Reprints of the Keller et al paper were distributed by GSK
the destructive consequences of ownership of data and industry
with Med Query Letters to physicians.
A whole industry has developed as a result of privatization called
As mentioned above, the most serious consequence of the
“medical communications.” At last count, there were close to 200
privatization of knowledge concerns the reporting of results from
such companies in the United States alone (Golden et al, 2002).
industry-sponsored clinical trials. When academic investigators
ese fi rms have been identifi ed as a major source of facilitating
enter into a contact with a pharmaceutical company, they will sign
misrepresentation in journal publications and in conference
a confi dentiality agreement that makes it clear from the outset
posters which they prepare for industry. For a modest fee, the
that the data produced in the trial is the property of the sponsor
drug company can retain control of the message via the medical
company and that any publication of results must be approved by
communication company it hires, reward KOLs with publication
company. In fact, before any publication appears the company
and thereby ensure that there is little risk that the named authors
signs off on release of the results to the named lead author thereby
will take control of the message communicated through the
transferring ownership of the paper. Physician-investigators who
paper. Study 329 was fi rst draft ed and then revised by a medical
have signed such contacts and then discovered in the course of
communications company, and there were very few meaningful
the trial that the drug they were testing presented a serious danger
changes (and therefore little scope for contribution by the named
to public health have found themselves in an ethical dilemma:
authors) from that fi rst draft to the published paper (McHenry
either remain silent and violate the primary obligation to patients’
health, or reveal the danger, face legal action and the destruction of their careers. Th
e cases of Nancy Olivieri, Betty Dong, Aubrey
Commercialization of science results in distorted priorities in
Blumsohn and John Buse are particularly noteworthy in this
research. Rush to blockbuster status for relatively trivial medical
connection because in their choice to reveal the danger, the sponsor
problems or disease-mongered creations for consumers in fi rst-
companies sought retaliation. (Schafer, 2004, Krimsky, 2004, Baty,
world countries dominate the research agenda rather than the
development of medicines for more serious problems throughout the world. Of 1393 new chemical entities marketed between 1975
In 2006 we were asked by the Baum-Hedlund law fi rm to do an
and 1999, only 16 were for tropical diseases and tuberculosis
independent analysis of study 329, sponsored by GlaxoSmithKline,
(Trouiller et al, 2002). Marcia Angell exposes the main business
on paroxetine (Paxil, Seroxat) use in adolescents. While it might
of the pharmaceutical industry as the development of “me-too”
seem hasty to extrapolate from this one trial, similar trials
drugs, namely, minor changes in the molecule of a blockbuster
conducted on rofecoxib (Vioxx) and gabapentin (Neurontin) have
drug that is just diff erent enough to qualify for a new patient
shown a pattern whereby the sponsor companies working with
(Angell, 2004, 76). So, drugs that treat heartburn, obesity, hair
medical communication companies have spun positive results
loss, toenail fungus, sexual performance, depression, allergies,
JEMH · April 2009 · 4(Sept. Suppl.) | 3
2009 Journal of Ethics in Mental Health (ISSN: 1916-2405)
high cholesterol, and the like will have a high priority in the
being, while in academe it serves a vital function in the pursuit
company while other important drugs that are less profi table will
of truth. Pharmaceutical marketing objectives identify academic
not be developed or will be discontinued. Examples of this latter
physicians as hostile adversaries of their drugs and seek strategies
group include certain anesthetics, antivenins, antidotes for drug
to ‘neutralize’ their criticism. One manner of accomplishing this
overdoses, anticlotting drugs, antibiotics, and vaccines against
objective is by alleging that doctors with concerns about effi
fl u and pneumonia, many of which are lifesaving treatments, but
and safety are secretly promoting competitors’ drugs (Coyne,
which have lesser appeal to industry because they are short-term
2005). Another is the co-option of KOLs to sign on to ghostwritten
rather than life-long treatments, or they treat diseases of the poor.
letters to the editors that defend the drugs against criticism. Th
An investigation into the development of HIV/AIDS drugs reveals
tactic creates the appearance of academic discourse, but in reality
that the real source of success was not profi t-inquiry via KOL
is nothing more than exploitation of the medical journals by
development, but rather liaisons between government, universities
pharmaceutical marketing (McHenry, 2005).
and other non-profi t research before the compounds were shift ed to private drug companies for further development, manufacture
All of the above has led to an erosion of confi dence both in the
and distribution (Angell, 2004, 25-27, 67-68).
wider medical community for the integrity of medical research and reporting of such research and in the public perception of
e industry-academe alliance has stifl ed academic freedom
and critical inquiry. As Fava has made the point: “Investigators who swim against the tide of corporate-driven research strategies may indeed have diffi
culty in publishing their fi ndings and
Co n c l u s i o n
observations” (Fava, 2004, 2). Commercial interests have come to dominate the content of academic medical journals. Advertising and reprint revenue alone raise serious questions about the degree
e profi t vs. knowledge-directed inquiry distinction can be
to which such journals can claim to be neutral arbiters in the
a false dichotomy if indeed profi t and knowledge motivations
attempt to produce a reliable body of knowledge (Lexchin and
merge to produce excellent scientifi c results and much needed
Light, 2006). What has become known as “commercially valuable
e evidence of the past twenty-eight years since
content,” allegedly good news about medical breakthroughs in
Bayh-Dole in the United States, however, suggests otherwise.
pharmaceuticals and medical devices much to the advantage of
While the short-term stimulus to biomedical research has been
the industry, has higher priority over bad news resulting from
much celebrated, the unintended, long-term consequences for
critical studies about manipulated results or ineff ective and unsafe
medicine have been severe. Scientifi c progress is thwarted by the
medicine. No advertising contracts or profi table reprint orders
ownership of knowledge, especially in clinical medicine where the
follow the publication of a study that demonstrates the failure of
adverse impact has reached an unprecedented crisis point (Fava,
clinical trial. Few journal editors seem to realize the degree to
2006). When the profi t motive dominates research agendas, there
which they have been infi ltrated by pharmaceutical marketing and
is relatively little confi dence in the results. Th
the strategy of the latter to use the journals as vehicles of promotion.
the medical community was summed up in a response to Angell’s
Richard Horton, in this connection argues that: “Medical journals
e New England Journal of Medicine, “Is Academic
have become an important but underrecognized obstacle to
Medicine for Sale?” with the quip, “No. Th
scientifi c truth” since they “have devolved into information
happy with it” (Ruane, 2000). Competition in industry prevents
laundering operations for the pharmaceutical industry” (Horton,
cooperative research and open, critical evaluation essential to
privatization of knowledge is the only source of confl ict of interest
Finally, instead of following the results of peer review, there
in medicine, but there is little doubt that it has accelerated such
is much evidence that the fi nal decision to publish is made by
confl icts since the 1980s. When knowledge, and especially that of
legal counsel to the journals. Papers that expose the extent of
critical concern to public health, becomes the private property of
scientifi c misconduct and manipulation of trial results in industry-
industry and academics are co-opted for the purpose of advancing
sponsored studies are routinely rejected due to fear of legal action
this interest, the society that enables such activity has lost all claims
brought by the companies (Healy, 2008). Our papers on study 329
to participate in the advance of science.
(Jureidini et al, 2008; McHenry and Jureidini, 2008) began life as an invited contribution by the editor of the British Medical Journal.
It may be impossible for medicine to sever its relations to its
Amongst the reasons for her rejection was a “combination of
pharmaceutical and medical device industries. Th
editorial and legal concerns that we feel are unlikely to be resolved
little doubt that restoring confi dence in the profession requires
even with a great deal of further work on your part and on the part
active protection of its autonomy and integrity. Since it seems
is raises an important question about academic
highly unlikely that there will be any reversal of legislation that
freedom when our journals routinely publish ghostwritten articles
led to the problem or competent government regulation, it is the
from industry-sponsored clinical research, but then reject critical
moral imperative of individual practitioners to eliminate confl ict
studies of those same publications on the basis that legal counsel
is demands fi rst of all a unifi ed eff ort of psychiatrists
to the journals has advised of potential libel actions brought by the
and other physicians to resist the relationships with industry that
pharmaceutical and medical device industries (McHenry, 2008).
have distorted results of clinical research and led to habits of
Industry infl uence on the medical journals has thus led to a form of
overprescription. Second, the profession must regulate itself by
censorship forced on editors. Under the business model, criticism
moral censure of practices that are profi t-oriented and ostracize
of products or processes is regarded as little more than competitors’
vying for market share and a hostile threat to the company’s well
a confi dentiality agreement with a sponsor company can claim
JEMH · April 2009 · 4(Sept. Suppl.) | 4
2009 Journal of Ethics in Mental Health (ISSN: 1916-2405)
scientifi c status for the results of the trial. As Wagner and Steinzor
make the point: “Science demands that, to the maximum extent
Jureidini, J. N., McHenry, L. B., Mansfi eld, P. R. (2008) “Clinical
possible, scientists have no stake in the outcome of the research”
Trials and Drug Promotion: Selective Reporting of Study 329,”
(Wagner and Steinzor, 2006, 6). Rigorous science can only exist
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Cambridge: Cambridge University Press.Acknowledgements: NoneCompeting Interests:Leemon McHenry is research consultant for Baum Hedlund law fi rm of Los Angeles, California. Jon Jureidini is engaged by Baum Hedlund to provide an independent analysis of the data in Study 329 and is chair of Healthy Skepticism, an international non-profi t organization with a main aim of countering misleading drug promotion. Address for Correspondence:Leemon McHenry Department of Philosophy California State University, Northridge 18111 Nordhoff Street Northridge, CA 91330-8253Email: leemon.mchenry@csun.edu
JEMH · April 2009 · 4(Sept. Suppl.) | 6
2009 Journal of Ethics in Mental Health (ISSN: 1916-2405)

PrEoPErativE PatiEnt instructions For skin surgEry You are scheduled to have excision of a skin lesion in our office using local anesthesia – the same type used in a dental office. You will be able to drive to and from our office unless you have taken sedative medications around the time of the procedure. The following instruc-tions will help to answer any other questions you may h

List of all Challenge substances This table represents the composition status of the substances in each batch as of the 26 December 2009 launch of Batch 12. The composition of each Challenge batch is confirmed 3 months before it is launched in the Canada Gazette Part 1. Substance Name Challenge Categorization Batch no. Decision Finalized Challenge Batches (as of the